FDA accepts BLA for lecanemab in early Alzheimer's

Japanese drugmaker Eisai’s (TYO: 4523) shares gained almost 6% to 6,167 yen after, along with partner Biogen (Nasdaq: BIIB), it announced that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) under the accelerated approval pathway for lecanemab (BAN2401).

Lecanemab is an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain. Eisai’s application, which was completed in early May 2022, has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of January 6, 2023.

“Alzheimer’s disease is a serious disease that causes significant disability and burden to the people living with Alzheimer’s disease and their families. Treatment options for Alzheimer’s disease are limited and creation of new treatment options is strongly encouraged. Eisai employees have spent time with people living with Alzheimer’s disease to truly understand their feelings and challenges and have been working to create new treatments for many years,” said Haruo Naito, chief executive at Eisai. “The acceptance of lecanemab's BLA with priority review is an important milestone in serving people living with Alzheimer’s disease who have been waiting for new treatment options to address an underlying pathology of Alzheimer’s disease. We will continue to actively cooperate with the FDA's review in an effort to bring this new treatment option to people living with Alzheimer’s disease and their families as soon as possible,” he noted.